The objective of this study is to confirm the safety and effectiveness of the Reducer when used in patients with refractory angina who demonstrate evidence of reversible ischemia.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CCS Angina Pectoris Classification: a decrease in two or more CCS angina
pectoris grades from baseline to six-month post-procedural evaluation in
Reducer and Control groups
Secondary outcome
1. Technical success: in the Reducer group, defined as successful delivery and
deployment of the Reducer to the intended site as assessed by the investigator
2. Procedural success: in the Reducer group, defined as technical success and
the absence of acute need for clinically -driven intervention to address an
Adverse or Serious Adverse Device Effect prior to hospital discharge, as
adjudicated by the Clinical Events Committee (CEC)
3. Periprocedural Serious Adverse Event (SAE): in the Reducer group, defined as
a composite of death, myocardial infarction (MI), cardiac tamponade,
clinically-driven re-dilation of a failed Reducer, life-threatening arrhythmias
(ventricular tachycardia [VT] or ventricular fibrillation [VF]), and
respiratory failure through 30 days post-procedure, as adjudicated by the CEC
4. Periprocedural SAE: in the Control group, defined as a composite of death,
MI, cardiac tamponade, life-threatening arrhythmias (VT or VF), and respiratory
failure through 30 days post-procedure, as adjudicated by the CEC
5. Major Adverse Events: a composite of cardiac death, major stroke, and MI in
the Reducer and Control groups through hospital discharge, and at 30-day,
three-month, and six-month post-procedural evaluations
6. CCS angina pectoris Classification: a decrease in CCS angina pectoris grades
from baseline to six-month post-procedural evaluation in Reducer and Control
groups
7. Dobutamine ECHO Wall Motion Score Index (WMSI): in the Reducer and Control
groups at baseline and six-month post-procedural evaluation
8. Seattle Angina Questionnaire (SAQ) Score: in the Reducer and Control groups
at baseline and six-month postprocedural evaluation
9. Total Exercise Duration (min), Time to ST-Segment Depression (min), and
Maximal ST-Segment Depression (mm) by Exercise Stress Test: in the Reducer and
Control groups at baseline and six-month post-procedural evaluation
Background summary
The treatment of patients with coronary artery disease is a lot improved in the
past years. Despite these improvements though, there are still many patients
for whom the quality of life is significantly affected due to their chronic
angina. This is a quickly growing group due to the increased life time and the
improved treatment methods. This groups is considered to be a no-option group,
where percutaneous coronary interventions and/or bypass surgery are no more
options, and the medications are not enough to improve symptoms.
Many different treatmen methods have been tested in the mean time with
different success. Fifty years ago, Dr. Beck surgically narrowed the coronary
sinus in order to distribute the blood flow over the myocardium. This resulted
in a significant reduction of the anginal complaints. This is at this moment, a
burdensome treatment for the patient.
The Neovasc Reducer is aiming to initiate the narrowing of the coronary sinus
in an interventional way. The method is similar to a stent implantation.
Study objective
The objective of this study is to confirm the safety and effectiveness of the
Reducer when used in patients with refractory angina who demonstrate evidence
of reversible ischemia.
Study design
A prospective, multicenter, randomized, double-blind, sham-controlled (1:1
randomization ratio), confirmatory clinical study of the safety and
effectiveness of the Reducer.
The following groups will be studied:
• Reducer Group: right heart catheterization as the last screening test,
followed by Reducer implantation, and completion of the catheterization
procedure
• Control Group: right heart catheterization as the last screening test,
followed by completion of the catheterization procedure
A Data Safety Monitoring Board (DSMB) will review summaries of safety
periodically. Two interim analyses will be performed. The first interim
analysis will occur after approximately 30 randomized patients have thirty-day
data available. The second interim analysis will include six-month safety and
effectiveness data of approximately 50% of the randomized population.
Intervention
Patients that fullfill all criteria will be randomized to:
• Reducer Group: right heart catheterization as the last screening test,
followed by Reducer implantation, and completion of the catheterization
procedure
• Control Group: right heart catheterization as the last screening test,
followed by completion of the catheterization procedure
The implantation of the Reducerr will be performed according the instructions
for us. The sponsor will support the implantation procedure.
Study burden and risks
The possible risk are most likely similar to a balloon angiogplasty, stent
implantation and the standard treatment after these procedures. The
implementation of the Reducer can lead to additional risks that are currently
unknown.
The additional burden are the hospital visits with an ECG, the anamnesis and
the completion of the questionnaire. After 6 months, a stress test, ECHO and
SPECT will be performed.
13700 Mayfield Place, Suite 2135
Richmond, BC V6V 2E4
CA
13700 Mayfield Place, Suite 2135
Richmond, BC V6V 2E4
CA
Listed location countries
Age
Inclusion criteria
- older than 18
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III of IV despite attempted optimal medical therapy for three months prior to screening
- Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
- Evidence of reversible ischemia that is atributable to the left coronary arterial system
- At least 1 mm ST-segment depression at baseline exercise testing
- Left ventricular ejection fraction greater than 25%
- Written informed consent prior to enrollment
- Patient is willing to comply
Exclusion criteria
- Recent (within three months) acute coronary syndrome
- Recent (within six months) PCI or CABG
- Unstable angina (recent onset angina, crescendo angina, of rest angina with ECG changes) during the thirty days prior to screening.
- De-compensated congestive heart failure (CHF) of hospitalisation due to CHF during the Three months prior to screening
- Life threatening rhythm disorders of any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
- Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predictec value
- Patient cannot undergo exercise stress test (treadmill) for reasons other than refractory angina
- Sever valvular heart disease
- Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
- Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodyalisis
- Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
- Contrainciation to required study medications that cannot be adequately controlled with pre-medication
- Known allergy to stainless steel or nickel
- Conainciation to having an MRI performed (NB: Cardiac MRI subset patients only)
- CUrrently enrolled in another investigational device or drug trial has not completed the primary endpoint or that clinically interferes with the current study endpoints;Angiographic
- Mean right atrial pressure higher than or equal to 15 mmHg
- Patient with anomalous or abnormal CS as demonstrated by angiogram, Abnormality definec as:
* abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or;
* CS diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36073.041.11 |